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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of MT027 in Patients with Pleural Malignant Tumors

A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors

A Study of MT027 in Patients with Pleural Malignant Tumors (NCT06726564) is a Phase 1 interventional studying Advanced Malignant Solid Tumor and Malignant Pleural Effusion, sponsored by Suzhou Maximum Bio-tech Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy.. Subjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Malignant Solid Tumor, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 18 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. voluntarily participate in the study and sign willing to sign a consent form; 2. age over 18 years old (including the cut-off value), regardless of gender; 3. advanced malignant solid tumor pathologically and/or histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary); 4. the original pleural cavity malignant tumor after standard treatment failure, or top treatment; 5. signed willing to sign a consent form not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture; 6. The subjects voluntarily provided sufficient tumor cells in the pathological section of the primary lesion and/or pleural effusion for B7-H3 expression detection, and the tumor cells in the pathological section of the primary lesion or malignant pleural effusion were positive for B7-H3 expression; 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2; 8. within 7 days before treatment laboratory meet the following criteria: Routine blood (14 days) : 1. Absolute neutrophil count (ANC) ≥1.5×109 /L; 2. platelet count (PLT) or 80 x 109 / L; 3. hemoglobin (HGB) or 80 g/L (allowing blood transfusion and use erythropoiesis agent). The presence of active bleeding or other ongoing conditions that result in increased red-cell destruction or impaired production may require repeated transfusions or red-cell therapy, and patients had to discuss their eligibility with the sponsor on an individual basis before enrollment.) ; Liver: 1. total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN); 2. no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis; Kidney: 1. Serum creatinine (Cr) ≤ 2 times ULN; Or creatinine clearance (CrCL) ≥ 50 mL/min (estimated by Cockcroft-Gault formula); Blood coagulation function: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. voluntarily participate in the study and sign informed consent; 2. age over 18 years old (including the cut-off value), regardless of gender; 3. advanced malignant solid tumor pathologically and/or histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary); 4. the original pleural cavity malignant tumor after standard treatment failure, or top treatment; 5. signed informed consent not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture; 6. The subjects voluntarily provided sufficient tumor cells in the pathological section of the primary lesion and/or pleural effusion for B7-H3 expression detection, and the tumor cells in the pathological section of the primary lesion or malignant pleural effusion were positive for B7-H3 expression; 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2; 8. within 7 days before treatment laboratory meet the following criteria: Routine blood (14 days) : 1. Absolute neutrophil count (ANC) ≥1.5×109 /L; 2. platelet count (PLT) or 80 x 109 / L; 3. hemoglobin (HGB) or 80 g/L (allowing blood transfusion and use erythropoiesis agent). The presence of active bleeding or other ongoing conditions that result in increased red-cell destruction or impaired production may require repeated transfusions or red-cell therapy, and patients had to discuss their eligibility with the sponsor on an individual basis before enrollment.) ; Liver: 1. total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN); 2. no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis; Kidney: 1. Serum creatinine (Cr) ≤ 2 times ULN; Or creatinine clearance (CrCL) ≥ 50 mL/min (estimated by Cockcroft-Gault formula); Blood coagulation function: 2. international standardization ratio (INR) or prothrombin time (PT) 1.3 x ULN or less; 3. Partial activated thromboplastin time (APTT) ≤ 1.5 times ULN; 9) toxicity from previous systemic therapy returned to grade 1 or less or to baseline before the first dose (except alopecia); 10) Fertile men and women of childbearing age must agree to use reliable contraception from the time they provide informed consent until 180 days after the last dose of MT027 cell injection; Women of childbearing age included those who were premenopausal and those within 2 years of menopause. Exclusion Criteria: 1. known allergy to the study drug or its excipients; 2. patients with pleural puncture contraindications or won't benefit from intrathoracic medication; 3. any antineoplastic drugs other than systemic antineoplastic therapy that the subject has been taking stably and any treatment that may have an effect on the control of pleural effusion (other than diagnostic puncture or thoracentesis for investigational treatment); 4. in the first test within 2 weeks before treatment received radiotherapy. 5. major surgery is performed within 4 weeks before the first trial treatment and the patient has not fully recovered; 6. are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week before the first trial treatment. 7. participated in other drug clinical trials within 4 weeks before screening; 8. always had targeted B7 - H3 CAR - T cells treatment; 9. patients with active systemic or pulmonary infection, coagulopathy and other major diseases; 10. with severe heart, lung, liver and renal insufficiency; Cardiac function: grade 3 or above according to the New York Heart Association (NYHA) criteria; Liver function: Child - Puge classification standard for grade C or above; Renal function: chronic kidney disease (CKD) stage 4 or above; Renal insufficiency stage Ⅲ or above; Pulmonary function: severe symptoms of respiratory failure involving other organs; 11. patients with severe autoimmune diseases; 12. recipients of previous allogeneic tissue/solid organ transplantation; 13. who received a live vaccine within 2 weeks before the first cell therapy or were scheduled to receive a live vaccine during the study; 14. active HBV infection; Or hepatitis C virus infection (defined as positive for HCV antibody, allowed if HCV-RNA was below the lower limit of detection); Or human immunodeficiency virus infection (defined as HIV antibody positive); Or positive treponema pallidum antibody; 15. subjects had severe neurocognitive impairment as judged by the investigator; 16. pregnant or lactating women; 17. There were any clinical or laboratory abnormalities or other reasons considered by the investigator to preclude participation in the study.

Treatments Being Tested

DRUG

MT027 cells suspension

MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06726564), the sponsor (Suzhou Maximum Bio-tech Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06726564 clinical trial studying?

This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy.. Subjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06726564?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06726564?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06726564. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06726564. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.